Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement

NCT05283980 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-10-01

No results posted yet for this study

Summary

The purpose of this study is to determine whether administration of a pectoral nerve blocks (Pecs I and II) with 0.25% bupivacaine are more effective as compared to placebo to provide analgesia for cardiac implantable electronic device (CIED) placement in cardiac electrophysiology lab

Conditions

  • Pain, Postoperative
  • Pain, Acute
  • Pain, Chest
  • Pain
  • Satisfaction, Patient
  • Opioid Use, Unspecified
  • Opioids; Harmful Use

Interventions

DRUG

0.25% Bupivacaine

The intervention group/ bupivacaine group will receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block in comparison to the control group that would receive 0.9% normal saline

Sponsors & Collaborators

Principal Investigators

  • Sankalp Sehgal, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-17
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05283980 on ClinicalTrials.gov